| CTRI Number |
CTRI/2023/04/051626 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Platelet-Rich Plasma on the rate of Orthodontic Tooth Movement and on the Biomarkers present in Gingival Crevicular Fluid – A Split Mouth Randomised Controlled Trial |
|
Scientific Title of Study
|
Effect of Platelet-Rich Plasma on the rate of Orthodontic Tooth Movement and on the Biomarkers present in Gingival Crevicular Fluid – An In-Vivo Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arundhati Das |
| Designation |
Orthodontic Resident |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Pune |
| Address |
B 602 Anandi Baug Society
kamgar nagar, kharalwadi road
Pune
MAHARASHTRA
411018
India |
| Phone |
09545841064 |
| Fax |
|
| Email |
arundhati2206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arundhati Das |
| Designation |
Orthodontic Resident |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Pune |
| Address |
B 602 Anandi Baug Society
kamgar nagar, kharalwadi road
MAHARASHTRA
411018
India |
| Phone |
09545841064 |
| Fax |
|
| Email |
arundhati2206@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arundhati Das |
| Designation |
Orthodontic Resident |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Pune |
| Address |
B 602 Anandi Baug Society
kamgar nagar, kharalwadi road
MAHARASHTRA
411018
India |
| Phone |
09545841064 |
| Fax |
|
| Email |
arundhati2206@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. DY Patil Dental College and Hospital, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Dr DY Patil Dental College |
| Address |
Sant Tukaram Nagar, Pimpri, Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Deshmukh |
Dr. D.Y Patil Dental College and Hospital |
Department of Orthodontics and Dentofacial Orthopedics
Room no. 3, First floor,
Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
9371009387
sonalivdeshmukh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Recognition Committee, Dr. D.Y. Patil Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers with dental malocclusion of protruding upper and lower teeth who need premolar extraction. participants between the ages of 16 years and 35years who has good periodontal health and no systemic medical history or metabolic bone disease were chosen for the study. |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional tooth movement |
normal physiologic tooth movement |
| Intervention |
Platelet rich plasma |
single dose of submucosal injection of prp into specific site on the root tip of the canine on the buccal and palatal sides. The injection will not be repeated again till the end of the trial |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
20 participants between the ages of 16 and 35 who have a full complement of teeth and good periodontal health and no severe medical history or metabolic bone disease will be chosen for the study. The selected subjects either had bimaxillary protrusion or Class II Division I malocclusion, undergoing orthodontic treatment and requiring extraction of 1st premolars |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for the trial will be those with periodontal diseases/poor oral hygiene, patients with autoimmune diseases, pregnancy, and lactation and those on medication (e.g. antibiotics, antihistamines, cortisone, hormones, and any other medication that may interfere with the inflammatory process or adversely affect the periodontium) and syndromic patients. |
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| INCREASED RATE OF TTOTH MOVEMENT BY ATLEAST 1.5% THAN NORMAL DUE TO THE EFFECT OF PRP |
We intend to check the amount of tooth movement at 1, 2 and 3 months time interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EFFECT OF BIOMARKERS IN THE GCF COLLECTED DURING THE 3 MONTHS OF TRIAL PERIOD |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Orthodontic Treatment requires the use of brackets and wires to
facilitate tooth movement and bring about alignment. This procedure takes an
average of about 24 months and sometimes more. There have been various studies
to reduce the treatment time and many methods have been put forth to bring
about faster tooth movement. These include acceleration of orthodontic tooth
movement by use of ultrasonic vibrations, photobiomodulation, low level laser
therapy, and use of pharmaceutical approach. One of the recently used local
agents to accelerate the rate of orthodontic tooth movement is platelet-rich
plasma (PRP). PRP is defined as an autologous concentration of platelets in a
minute volume of plasma. The alpha granules in the platelets are the most
abundant secretory granules. They contain numerous proteins, including growth
factors and chemokines, which are crucial for primary hemostasis and wound
healing. Additionally, the rate of orthodontic movement can be studied through
the biomarkers present in the Gingival Crevicular Fluid(GCF) which is a
gingival exudate. Using the knowledge of the biochemical changes taking place
in the GCF following the use of PRP, we can attempt to synthetically alter the
tooth movement and accelerate our treatment time.
Novelty: We plan to use the information in accelerating orthodontic treatment
time in adults so that more adult patients can seek orthodontic treatment.
Objectives: The study’s objective is to find the effect of PRP on the
rate of tooth movement and on the biomarkers that are present in GCF.
Methods: The method would include injecting a small amount of PRP which would be
prepared from the patient’s own blood, into the desired site in the mouth.
Later, GCF samples would be collected from these sites at designated time intervals
to study the effect of PRP on the biomarkers in GCF.
Expected outcome:
1)Intervention side tooth movement will be accelerated.
2)Identification of biomarkers responsible for enhanced tooth movement.
3) Isolated Biomarkers for faster tooth movement therapy. |